Hims & Hers Health, Inc. dba Hers – FDA Warning Letter, Aug 1, 2025

On September 9, 2025, the FDA issued a Warning Letter to Hims & Hers Health, Inc. (dba Hers) following an August 2025 review of the company"s website. The agency identified significant violations related to the marketing of compounded semaglutide products. The FDA concluded that the company"s promotional claims were false or misleading, specifically citing language that suggested their compounded drugs were the same as FDA-approved medications like Ozempic and Wegovy. Because compounded drugs are not FDA-approved, claims of having the "same active ingredient" or being "clinically proven" are considered deceptive. Under the regulatory framework of the Federal Food, Drug, and Cosmetic Act (FDCA), these products are classified as misbranded drugs. Specifically, the company violated sections 502(a) and 502(bb) regarding false labeling and advertising, as well as section 301(a) concerning the distribution of misbranded products in interstate commerce. The FDA requires Hims & Hers to take immediate action to correct these violations, including ceasing the use of the misleading marketing language. The company must provide a written response within 15 working days outlining the specific steps taken to address the issues and prevent their recurrence. Failure to comply may lead to legal actions such as product seizure or injunctions.